NCT05216068

Brief Summary

Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

January 23, 2022

Last Update Submit

February 19, 2025

Conditions

Chromosome TranslocationGenetic Disorders in PregnancyRecurrent Miscarriage

Keywords

pre-implantation genetic diagnosisbalanced reciprocal translocation (BRT)structural variation (SV)next generation sequencingabandoned blastocysts

Outcome Measures

Primary Outcomes (1)

  • Blastocyst aneuploidy rate

    anormal Karyotype according to human genome 19 or updated version

    28 days

Secondary Outcomes (1)

  • Whole genome amplification rate

    7 days

Study Arms (1)

donated abandonment embryos

OTHER

Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC.

Diagnostic Test: NGS

Interventions

NGSDIAGNOSTIC_TEST

Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.

donated abandonment embryos

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • the surplus blastocysts
  • parents consent to donate the embryos

You may not qualify if:

  • not agree to participate in this program
  • whose embryo morphology and quality do not meet the technical requirements for genetic testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 123, Taiwan

Location

MeSH Terms

Conditions

Translocation, GeneticAbortion, Habitual

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and SymptomsAbortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2022

First Posted

January 31, 2022

Study Start

December 1, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

TW(1)